Continuing with FDA-related scholarship posted on SSRN in February and March: Professor Noah explores the possibility of “reverse switches” from over-the-counter (OTC) status back to prescription status (or perhaps, he suggests “behind the counter” status) in response to new safety information. Professor Paradise explains the provisions of the 21st Century Cures Act that contemplate greater patient involvement in medical product development, and Professors Evans and Ossorio evaluate the 21st Century Cures Act exclusion of clinical decision software from the agency’s medical device authority.
Many scholars posted articles relating to FDA law in February and March. To do these articles justice, I am breaking my report into three parts. Below, Rachel Sachs takes on drug prices by proposing we no longer require payers to cover new drugs simply because FDA has approved the drugs; Laurie Beyranevand and Diana Winters would have the states step in where FDA has not been, in their view, aggressive enough (thus, banning substances in food that are deemed safe by their manufacturers but not reviewed by FDA, and banning use of antibiotics in food-producing animals for purposes of growth enhancement); and Robin Feldman and colleagues publish a succinct new summary of their empirical research on citizen petitions that relate to pending generic drug applications.